Dietary Intakes and Periodontal Health: A Follow-Up Study

Periodontal Pocket Clinical Trial

Official title:

Dietary Intakes and Periodontal Outcomes After Sanative Therapy: A Follow-Up Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073174
• Other study ID #: 16-131
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: May 2018
• Source: Brock University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A previous study, on which this study is based, found that a diet higher in fruits and vegetables, beta-carotene, vitamin C, alpha-tocopherol, and fish oils (specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) was positively associated with periodontal healing after sanative therapy (NCT02291835). The investigator's next step, in the present study, is to determine long-term benefits of sanative therapy in which patients have regular maintenance hygiene cleanings on periodontal health. Specifically, the relationship between intakes of specific foods, nutrients and supplements with clinical periodontal outcomes will be studied.

Description:

Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Sanative therapy is a non-surgical process involving mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. Participants in this present study previously underwent sanative therapy several years ago and have been attending the clinic for regular maintenance appointments to maintain periodontal health. While significant associations were observed with higher intakes of fruits and vegetables and specific nutrients (vitamins C and E, beta-carotene, fish oils) within a few months after sanative therapy, this study will follow-up these findings to determine if such relationships persist during a period of relatively stable periodontal health. Given new insights into a potential role of flavonoids in maintaining periodontal health, this aspect will also be studied. The overall objective is to determine if higher intakes of foods, nutrients and supplements known to have osteogenic and immunomodulatory effects are associated with improved clinical outcomes in individuals who previously underwent sanative therapy. At the regular maintenance appointment, clinical measures will be evaluated (clinical attachment loss, probing depth, bleeding on probing, plaque index). As well, the following will be evaluated: dietary intakes of macronutrients and micronutrients using the Block 2015 food frequency questionnaire; intakes of fruit, vegetables and fiber using the Block Dietary Fruit-Vegetable-Fiber Screener; nutritional supplement use and tea intake using specially developed questionnaires and salivary markers of inflammation using biochemical assays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• previously participated in the original study (NCT02291835)

Exclusion Criteria:

• under 19 years of age

• have not participated in the previous study as this study is a direct follow-up of those participants

Related Conditions & MeSH terms

• Periodontal Attachment Loss
• Periodontal Pocket

Locations

Country	Name	City	State
Canada	Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery	Fonthill	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Brock University	Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dietary Nutrient Intakes	Dietary intakes measured using the Block food frequency questionnaire	At maintenance appointment (1 hour)
Other	Tea Intakes	Quantity and type of tea consumed will be determined using a questionnaire	At maintenance appointment (1 hour)
Other	Servings of Fruits, Vegetables and Fiber	A questionnaire called the Block Fruit-Vegtable-Fiber Screener is used to provide a score that pertains to number of servings of fruits, vegetables and fiber consumed over past month	At maintenance appointment (1 hour)
Other	Dietary Supplement Intakes	Intakes of specific dietary supplements measured using a dietary supplement questionnaire	At maintenance appointment (1 hour)
Other	Salivary Markers of Inflammation	Specific markers of inflammation measured in saliva	At maintenance appointment (1 hour)
Primary	Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)	Clinical Attachment Loss is a routine clinical measure of periodontal health (measured in mm)	At maintenance appointment (1 hour)
Secondary	Probing Depth	Probing depth is a routine clinical measure of periodontal health (measured in mm)	At maintenance appointment (1 hour)
Secondary	Bleeding on Probing	Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth.	At maintenance appointment (1 hour)
Secondary	Plaque Index	O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of the tooth.	At maintenance appointment (1 hour)